Benesta Tissue Removal Device
FDA 510(k) K233500 · Caldera Medical, Inc.
510(k) numberK233500
Submission
- Device name
- Benesta Tissue Removal Device
- Applicant
- Caldera Medical, Inc.
Westlake Village, CA, US - Received
- October 31, 2023
- Decision date
- November 30, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HIH – Hysteroscope (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1690
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HIH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254294 | Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A…HIH · Traditional | Zhejiang Geyi Medical Instrument Co., Ltd. | 09/08/2026SE |
| K260984 | HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)HIH · Traditional | Axora Medical, Inc. | 08/18/2026SE |
| K253020 | Strauss Surgical Resection InstrumentsHIH · Traditional | American Medical Endoscopy, Inc. | 06/04/2026SE |
| K254050 | Manual Tissue Removal DeviceHIH · Traditional | Suzhou AcuVu Medical Technology Co., Ltd. | 05/15/2026SE |
| K254251 | InnovexView (GC146-17, GC150-20, GC155-23)HIH · Traditional | Shanghai AnQing Medical Instrument Co., Ltd. | 02/26/2026SE |
| K252793 | ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope…HIH · Traditional | Jiangsu Jiyuan Medical Technology Co., Ltd. | 12/18/2025SE |
| K252012 | SPY Cystoscope/HysteroscopeHIH · Special | Stryker Endoscopy | 07/18/2025SE |
| K243382 | RZ Resectoscope SystemHIH · Traditional | Rz Medizintechnik GmbH | 06/03/2025SE |
| K240978 | SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G…HIH · Traditional | MacroLux Medical Technology Co., Ltd. | 08/16/2024SE |
| K241987 | Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)HIH · Special | Guangzhou Red Pine Medical Instrument Co., Ltd. | 08/02/2024SE |
More from Guangzhou Red Pine Medical Instrument Co., Ltd.
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| K211975 | Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara…OTN · Special | 11/10/2021SE |
| K192811 | BenestaTM Tissue Removal DeviceHIH · Traditional | 10/23/2020SE |
| K192822 | Benesta HysteroscopeHIH · Traditional | 09/09/2020SE |
| K193603 | Benesta Medical Sterilization TrayKCT · Traditional | 07/20/2020SE |
| K191416 | Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling…PAH · Traditional | 02/07/2020SE |
| K172614 | Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator…PWJ · Traditional | 05/04/2018SE |
| K162201 | Desara TV, Desara Blue TVOTN · Traditional | 01/11/2017SE |
| K150023 | Vertessa Lite Y-MeshOTO · Traditional | 04/06/2015SE |
| K150016 | Vertessa LiteOTO · Traditional | 04/06/2015SE |
| K140843 | Desara Blue Ov, Desara Blue SSOTN · Special | 07/01/2014SE |
Questions and answers
When was Benesta Tissue Removal Device cleared by the FDA?
Benesta Tissue Removal Device (K233500) received a 510(k) decision of Substantially Equivalent on November 30, 2023, 30 days after the submission was received.
What is the product code of K233500?
The FDA product code is HIH – Hysteroscope (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1690.